Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.  

The Clinical Trial Associate I (CTA I) is primarily responsible for developing and supporting the infrastructure of the clinical trial throughout the project lifecycle.  The CTA I works directly with the Site Activation Manager (SAM), Project Manager (PM), Clients, vendors, and other internal functional teams to ensure quality deliverables on-time and on-budget. Our mission is for our Catalyst staff to operate seamlessly with our customer teams using the Catalyst site centric model to enhance employee satisfaction while giving the sites and customers the reassurance that they have a strong, experienced team in all functional areas. This role requires oversight and mentorship with a senior CTA or CSS manager.

Clinical Trial Responsibilities and Accountabilities:

Under the direction of an assigned mentor or CSS manager, complete the following:      

·      Participate as an active member of the project team from the hand over meeting   

       from feasibility team member to study transfer or closeout.

·      Maintain and coordinate logistical aspects of assigned clinical trials according to

       GCP and ICH relevant SOPs.

·      Provide support to the PM in aspects of trial management not limited to the

       following:

       o   Creation and distribution of meeting agendas, minutes, decision logs, action item

            tracking, and slide deck as requested.

       o   Develop and maintain internal and external study team and site contact lists.

       o   Build and maintain the study team training tracker.

       o   Produce debarment checks

       o   Set up and maintain CTMS or other centralized system.

       o   Organize and request shipments of non-IP supplies.

       o   Prepare and distribute Investigator Site File binders to clinical sites.

       o   Maintain trackers for study systems and assist with granting access to

             appropriate study members.

       o   Manage post-activation central IRB tasks.

       o   Assist with creation and distribution of monthly status report and site newsletters

·       Responsible for or assist with SUSAR distribution and Ethics Committee (EC)

        submissions.

·       Ability to execute the technical aspects of all sites’ regulatory documentation and

        compliance during the conduct of clinical research studies as needed.

·       Assist cross-functional central site services teams to update feasibility and study  

        start up trackers as well as review  essential document packages to meet start up

        timelines.

·      Address any issues in a timely and responsible manner and put control measures in

        place to prevent recurrences to ensure project deliverables are met according to

        agreed timelines and milestones and quality expectations.

·      Supports implementation of technology enabled processes and identifies new  

       technology solutions to improve overall efficiency within the Clinical Operations

       group.

·      Develops effective and productive partnerships with strategic business partners as

        well as client team members to ensure clarity of role, deliverables and achievement

       of project goals and objectives.

·      Self-directed in task execution to ensure project deliverables are met.

·      Proactive problem solver who either solves issues on their own or raises them to the

       appropriate level of management to facilitate a solution.

·      Works closely with Sponsors under the direction of the PM in support of project

       services being delivered. 

·      Maintains quality control and quality assurance process for project support, liaising

        with sponsors as necessary to obtain and investigate feedback on quality and 

        turnaround times.

·      Responsible for ensuring all study documents are archived based on the appropriate

       guidelines/policy.

·      Responsible for understanding the CSS responsibilities on each project.

·      Contribute to development and improvement of quality processes.

·      Assist with the compilation of the Clinical Study Report appendices.

·      Participate in reviewing job aids, manuals, guidance documents and training

       materials.

Project Oversight and KPI responsibilities:

Under close supervision of assigned mentor or CSS manager:

·       Track and report on eTMF KPIs

·       Responsible for oversight of the filing and quality control of the Trial Master File by

         all functional areas throughout the lifecycle of the project.

·       Coordinate the eTMF reconciliation process and eTMF Transfer deliverables for the

        study team.

·       Assess and report on eTMF document management status, performance metrics,

        issues, and lessons learned to appropriate parties.

·       Responsible for managing all activities associated with the TMF services for which

        Catalyst is contracted, developing best practice guidelines, and overseeing project

        team   compliance.

Process Development Responsibilities:

·       May contribute to non-study related projects or initiatives.

QA and Study Audit Responsibilities:

Under close supervision of assigned mentor or CSS manager:

·       Responsible for ensuring that project documentation is complete and audit ready.

·       Participate in the audits.

·       Address questions in the audit reports.

         Support study audits and respond to audit reports.

Managerial Requirements/ Responsibilities: N/A

Position Qualification Requirements:

Education: Associate degree (or equivalent) or comparable industry experience.

Experience: Prefer basic clinical development and business experience familiar with the clinical and study management operational requirements. Basic administrative experience is required.

Required Certifications: N/A

Required Skills:

·       Strong organizational skills.

·       Technical capabilities in computers, software packages (PowerPoint, Excel, Access,

         Project, Publisher, Visio), Clinical Trial Management Systems (CTMS) and Trial

        Master  Files  (TMF)

·       Excellent written and verbal capabilities that facilitate internal and external

        communications.

·       Ability to multi-task across a broad set of tasks.

·       Self-motivation and direction in alignment with the overall company goals and

        objectives. 

·       Exercises sound judgment and problem solving in situations where there is limited

        information directing the solution to the problem.

        Team player and proactive problem solver

·       Exceptional written and verbal communication skills.

·       Ability to read, write and speak fluent English.

·       Familiarity with Microsoft Outlook and business email etiquette.

·       Good working knowledge of a range of computer applications.

·       Proficient in Microsoft office (Word, Excel, PowerPoint, Teams, SharePoint).

·       Occasional travel to closest Catalyst or Sponsor office, as needed.